LBPO.CL04 · 临床研究 · Late-Breaking

体外光分离置换疗法与全身免疫抑制治疗免疫相关不良事件的比较：前瞻性双臂PRIA研究的最终分析

Extracorporeal photopheresis vs. systemic immunosuppression for treatment of immune-related adverse events: Final analysis of the prospective two-arm PRIA study

编号 LB421 展板 11 时间 4/22 09:00–12:00 区域 Section 51 主讲 Lisa Wein

分会场 Late-Breaking Research: Clinical Research 4

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作者与单位 Authors & Affiliations

Lisa Wein¹, Carolin Ertl¹, Theresa Ruf¹, Monika Morak¹, Ying Wang¹, Christina Schmitt¹, Xiomara Garza Vazquez¹, Valerie Glatzel¹, Richard David-Rus¹, Mohammed Mitwalli², Jerome Srour¹, Pia Schöpf¹, Dirk Tomsitz¹, Lars E. French³, Lucie Heinzerling¹

¹LMU University Hospital, Munich, Germany,²Division of Dermatology, Department of Medicine, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada,³Department of Dermatology and Cutaneous Surgery, University of Miami, Miami, FL

摘要 Abstract

中文摘要

目的：检查点抑制剂诱导的免疫相关不良事件（irAE）可表现为激素难治性（sr）或激素依赖性（sd），需要二线治疗。本研究比较了体外光分离置换疗法（ECP）与免疫抑制剂（IS）在处理sr/sd-irAE中的作用，兼顾irAE缓解与抗肿瘤疗效之间的平衡。患者：这项前瞻性双臂研究分析了46例患者（23例ECP，23例IS），涵盖12种不同的sr/sd-irAE和5种不同的肿瘤类型。毒性累及胃肠道、皮肤、肺、肌肉骨骼系统和浆膜，既往针对irAE的治疗线数最多达7线。患者接受为期12周的六个周期ECP或研究者选择的IS治疗，并纵向评估irAE结局、生活质量（QoL）、肿瘤反应及血液分析。结果：在第12周，ECP组表现出更高的临床irAE缓解率（94%对81%；p = 0.22）、改善的QoL评分（p = 0.01），且所需激素显著少于IS队列，累积泼尼松龙当量分别为437 mg对1405 mg（p = 0.02）。与IS组相比，患有晚期皮肤黑色素瘤的ECP患者表现出更优的总生存期（15个月对10个月；p = 0.02）、更长的无进展生存期（9个月对3个月；p = 0.01）以及更低的癌症进展率（33%对67%；p = 0.12）。ECP在多毒性病例（44%对9%；p = 0.016）和既往二线治疗难治患者（39%对17%；p = 0.19）中使用更为频繁。ECP未观察到显著的安全性问题；IS组的1例死亡与免疫抑制下的感染有关。结论：ECP在处理sr/sd-irAE方面较IS表现出临床优越性，安全性良好，并保留了抗肿瘤反应。计划开展一项多中心试验以作进一步研究。

查看英文原文 English abstract

Purpose : Checkpoint inhibitor-induced immune-related adverse events (irAEs) can be steroid-refractory (sr) or steroid-dependent (sd), necessitating second-line therapy. This study compared extracorporeal photopheresis (ECP) with immunosuppressants (IS) in managing sr/sd-irAEs, balancing irAE mitigation with anti-tumor efficacy. Patients : This prospective, two-arm study analyzed 46 patients (23 ECP, 23 IS) with 12 distinct sr/sd-irAEs and five different tumor entities. Toxicities affected the gastrointestinal tract, skin, lung, musculoskeletal system, and serosal membranes, with up to seven prior treatment lines for irAEs. Patients underwent 12 weeks of either six cycles of ECP or investigator's choice IS, with longitudinal assessment of irAE outcome, quality of life (QoL), tumor response, and blood analyses. Results : At week 12, the ECP group exhibited a higher clinical irAE response rate (94% vs. 81%; p = 0.22), improved QoL scores (p = 0.01) and required significantly less steroids than the IS cohort with 437 mg vs. 1405 mg cumulative prednisolone equivalent, respectively (p = 0.02). ECP patients with advanced cutaneous melanoma showed superior overall survival (15 vs. 10 months; p = 0.02), longer progression-free survival (9 vs. 3 months; p = 0.01), and lower cancer progression rates (33% vs. 67%; p = 0.12) compared to the IS group. ECP was more frequently utilized in multi-toxicity cases (44% vs. 9%; p = 0.016) and in patients with prior second-line treatment refractoriness (39% vs. 17%; p = 0.19). No significant safety concerns were observed with ECP; one fatality in the IS group was linked to infection under immunosuppression. Conclusion : ECP demonstrates clinical superiority over IS in managing sr/sd-irAEs, with a favorable safety profile, and preserved anti-tumor response. A multicenter trial is planned for further investigation.

利益披露 Disclosure

L. Wein, None. C. Ertl, BMS Independent Contractor. GSK Independent Contractor. Immunocore Independent Contractor. Kyowa Kirin Independent Contractor. MSD Independent Contractor. T. Ruf, None.. M. Morak, None.. Y. Wang, None.. C. Schmitt, None.. X. Garza Vazquez, None.. V. Glatzel, None.. R. David-Rus, None.. M. Mitwalli, None. J. Srour, Derma2Go Independent Contractor. Abbvie Independent Contractor. Almirall Independent Contractor. Novartis Independent Contractor. La Roche Posay Independent Contractor. BMS Independent Contractor. Leo Independent Contractor. UCB Independent Contractor. Beiersdorf Independent Contractor. Boehringer Ingelheim Independent Contractor. P. Schöpf, None. D. Tomsitz, BMS Independent Contractor. Roche Independent Contractor. Novartis Independent Contractor. Sanofi Independent Contractor. Recordati Independent Contractor. Kyowa Kirin Independent Contractor. Sun Pharma Independent Contractor. Pierre Fabre Independent Contractor. L. E. French, Janssen Independent Contractor. Leo Pharma Independent Contractor. Eli Lilly Independent Contractor. Almirall Independent Contractor. Union Therapeutics Independent Contractor. Regeneron Independent Contractor. Novartis Independent Contractor. Amgen Independent Contractor. Abbvie Independent Contractor. UCB Independent Contractor. Biotest Independent Contractor. Boehringer Ingelheim Independent Contractor. InflaRx Independent Contractor. Alys Pharmaceuticals Independent Contractor. L. Heinzerling, BiomeDx Independent Contractor. BMS Independent Contractor, ). Kyowa Kirin Independent Contractor. Merck Independent Contractor, ). MSD Independent Contractor. Myoncare Independent Contractor. Novartis Independent Contractor, ). Pierre-Fabre Independent Contractor, ). Roche Independent Contractor. Sanofi Independent Contractor. SUN Independent Contractor. Therakos Independent Contractor. Agenus ). AstraZeneca Inc. ). Hoffmann-La Roche AG ). Huya Bioscience ). Immunocore ). IO Biotech ). Merck Sharp & Dome GmbH ). Miltenyi Biomedicine GmbH ), Other, Additional Company Researcher/Grabt/Contract: Pfizer, Regeneron, Replimune, and Sanofi Aventis.

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